Bengaluru, India, Mar 06, 2019
"This is to inform you that the U.S. FDA concluded a pre-approval inspection of Biocon's insulin drug
substance manufacturing facility triggered by a New Drug Application submitted by our insulin API
The inspection at the Bengaluru facility took place between 25th Feb - 5th Mar, 2019, resulting in a Form 483 with six observations.
Biocon is confident of addressing these expeditiously and remains
committed to global standards of Quality and Compliance"
- Company Spokesperson